F1ANNEX VI
F1PART IIUNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS
F1C.DECISION-MAKING
F11.General principles
F11.1.
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F11.2.
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F11.3.
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F11.4.
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F11.5.
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F11.6.Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:
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F11.7.Before issuing authorisations, Member States shall:
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F11.8.No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of:
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F11.9.Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):
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F11.10.
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F11.11.
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F11.12.
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F11.13.
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F11.14.
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F12.Specific principles
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F12.1.Identity
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F12.2.Biological and technical properties
F12.2.1.
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F12.2.2.
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F12.3.Further information
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F12.4.Efficacy
F12.4.1.Performance
F12.4.1.1.
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F12.4.1.2.
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F12.4.1.3.
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F12.4.1.4.
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F12.4.1.5.Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
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F12.4.1.6.
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F12.4.1.7.
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F12.4.2.Absence of unacceptable effects on plants and plant products
F12.4.2.1.
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F12.4.2.2.
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F12.4.2.3.
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F12.4.2.4.
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F12.4.2.5.
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F12.4.2.6.
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F12.4.2.7.
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F12.4.2.8.
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F12.5.Identification/detection and quantification methods
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F12.5.1.
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F12.5.2.No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of:
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F12.6.Impact on human and animal health
F12.6.1.Effects on human and animal health arising from the plant protection product
F12.6.1.1.
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F12.6.1.2.No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
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F12.6.1.3.All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
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F12.6.1.4.
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F12.6.1.5.
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F12.6.1.6.
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F12.6.1.7.
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F12.6.1.8.
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F12.6.1.9.
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F12.6.2.Effects on human and animal health arising from residues
F12.6.2.1.
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F12.6.2.2.
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F12.7.Fate and behaviour in the environment
F12.7.1.
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F12.7.2.
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F12.7.3.No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:
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F12.7.4.No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:
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F12.7.5.
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F12.7.6.
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F12.7.7.
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F12.8.Effects on non-target organisms
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F12.8.1.Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:
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F12.8.2.Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:
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F12.8.3.Where there is a possibility of bees being exposed, no authorisation shall be granted:
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F12.8.4.Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:
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F12.8.5.
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F12.8.6.
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Repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.